The epinephrine nasal spray, called neffy, is for emergency treatment of allergic reactions, including anaphylaxis, in adult and pediatric patients weighing approximately 66 pounds or more, according to an Aug. 9 news release from the agency.
The approval is based on four studies in 175 healthy adults that showed similar blood concentration levels of epinephrine when using the nasal spray compared to injection products.
The spray is administered as a single dose into one nostril. A second dose in the same nostril can be administered if symptoms do not improve or worsen, similar to guidelines for epinephrine injection products, the release said.
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